Kraff 1982.

Methods	Study design: Parallel group RCT
Participants	Country: USA Setting: Eye hospital Intervention: NSAIDs plus steroids Number of people (eyes) randomised: 330 (NR) Number (%) of people followed up: 323 (98%) Average age in years: 69 Age range in years: 37‐91 Percentage women: 60% Ethnic group: NR Percentage with diabetes: NR Percentage with uveitis: NR Comparator: Steroids plus placebo Number of people (eyes) randomised: 170 (NR) Number (%) of people followed up: 169 (99%) Average age in years: 68 Age range in years: 45‐97 Percentage women: 54% Ethnic group: NR Percentage with diabetes: NR Percentage with uveitis: NR Included criteria: Eligible for extracapsular cataract extraction with implantation of a Shearing posterior chamber lens. Excluded criteria: NR Pretreatment: None noted; age, gender, follow‐up and endothelial cell density preoperative compared. Eyes: Unclear if one or both eyes included.
Interventions	Intervention: NSAIDs plus steroids indomethacin (brand name not reported) Times per day: 5 times every 10 to 15 mins 18 hrs before surgery; 1 x 12 hrs before surgery; 1 x at bedtime; 1 x 2 hrs before surgery; 1 x 1.5 hrs before surgery; 1 x 30 mins before surgery; 4 times a day postoperative Duration preoperative: days: 1 Duration postoperative: days: 274 dexamethasone (in combination with neomycin sulfate, polymyxin B sulfate) for 4 days followed by dexamethasone alone for 4 weeks followed by fluorometholone for at least 6 months (Maxitrol and Maxidex) Times per day: 4 times a day (dexamethasone) and 3 times a day (fluorometholone) Duration preoperative: days: 1 Duration postoperative: days: 274 Comparator: Steroids plus placebo dexamethasone (in combination with neomycin sulfate, polymyxin B sulfate) for 4 days followed by dexamethasone alone for 4 weeks followed by fluorometholone for at least 6 months (Maxitrol and Maxidex) Times per day: 4 times a day (dexamethasone) and 3 times a day (fluorometholone) Duration preoperative: days: 1 Duration postoperative: days: 274 placebo (vehicle) Times per day: 5 times every 10 to 15 mins 18 hrs before surgery; 1 x 12 hrs before surgery; 1 x at bedtime; 1 x 2 hrs before surgery; 1 x 1.5 hrs before surgery; 1 x 30 mins before surgery; 4 times a day postoperative Duration preoperative: days: 1 Duration postoperative: days: 274 Type of surgery: ECCE and phacoemulsification (unplanned ICCE n = 19 were excluded).
Outcomes	Follow‐up: between 2.5 and 12 months. Quote: "The mean interval between surgery and angiography was 4.1 months, with a range of 2.5 to 12 months. Ninety percent of the angiograms were performed between 2.5 and 5 months after surgery, and 10% between 6 and 12 months after surgery." Adverse effects CMO (fluorescein angiography using Miyake 1977) Snellen acuity only (not included in the analyses).
Contact details	Authors name: Manus C Kraff Institution: Abraham Lincoln School of Medicine, University of Illinois Email: NR Address: 5600 W. Addison Street, Chicago, IL 60634
Notes	Funding sources: Core Grant EY 1792 NEI Bethesda Maryland Declaration of interest: NR Date study conducted: NR Trial registration number: NR Contacting study investigators: Trial authors not contacted.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Judgement comment: Randomisation was using a table of random numbers.
Allocation concealment (selection bias)	Unclear risk	Judgement comment: Not reported how allocation administered.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement comment: Quote: "The study was double‐masked; neither the physician nor the patient knew what drops the patient was receiving."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement comment: Quote: "The study was double‐masked; neither the physician nor the patient knew what drops the patient was receiving." Quote: "The angiograms were read in a masked fashion by a retired specialist (LMJ) who had no knowledge of either the drug regimen or the type of surgical procedure."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Judgement comment: Some patients were excluded (n = 19) and not reported: two with vitreous loss, two with vitreous pressure and a shallow anterior chamber and 15 with possible rupture of the posterior capsule. Unclear which groups these were in. Follow‐up high for visual acuity (> 95%) but lower for CMO (60% in indomethacin group versus 64% in placebo).
Selective reporting (reporting bias)	Unclear risk	Judgement comment: No access to protocol or trial registry entry.